Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06789172 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors

Study acronym: INVOKE
StatusRecruiting
PhasePhase 1
SponsorEpkin
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modifiedv12 Show 5 more changesShow less
    • Enrollment reduced: 166 → 146 participants
    • Trial arms changed: 9 → 7
    • Secondary endpoints: 27 to 29
    • Publications expanded, about 64 words
    • Eligibility criteria expanded, about 1 word
  2. Re-verified, no change to tracked fieldsv11
  3. Study sites: 8 to 10v10
  4. Site contacts updated at 1 of 8 sitesv9
  5. Study sites: 7 to 8v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 5 to 7v7
  2. Study sites: 4 to 5v6
  3. Study sites: 3 to 4
    • Interventions: Fasting (Other), Fed (Other), OKN4395 (Drug), Pembrolizumab (Combination Product) to Fasting (Other), Fed (Other), H2 Receptor Antagonist (Drug), OKN4395 (Drug), Pembrolizumab (Combination Product)
    • Eligibility criteria expanded, about 53 words
    • Study arms: 22 to 9
    v5
  4. Site contacts updated at 1 of 3 sitesv4
  5. Study sites: 2 to 3v3
  6. Start date changed from estimate of Jan 2025 to Jan 23, 2025v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Epkin
1 trial monitored
See all monitored trials
Lung Cancer
4,790 trials monitored
See 263 trials at risk
Colorectal Cancer
3,394 trials monitored
See 159 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,078 trials monitored
See 172 trials at risk
and 3 more diseases
The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab. The overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab. This study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more participants completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1a also includes a parallel substudy (Substudy 1) consisting of at least 12 participants, aiming to test the effect of food and stomach acid on the levels of OKN4395 in the blood as well as its tolerability. Part 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 4 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 in non-small cell lung cancer (NSCLC), Cohort 3 in colorectal cancer, and Cohort 4 in gastric cancer (GC), with cohorts 2 to 4 in combination with pembrolizumab. The overall study will enrol approximately 146 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 80 participants in Part 1b split: 20 on monotherapy and 60 on combination therapy. The study will be conducted in the US, Australia, UK and in the EU.
Trial Details
NCT Number NCT06789172
Lead Sponsor Epkin
Collaborators: Precision For Medicine
Conditions
(from sponsor)		 Solid Tumours, Sarcoma, HNSCC, Non Small Cell Lung Cancer, NSCLC, Colorectal Cancer (CRC), Myxofibrosarcoma (MFS), Solitary Fibrous Tumors +7 more
Related terms Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Dermatofibrosarcoma, Histiocytoma, Malignant Fibrous, Leiomyosarcoma, Liposarcoma, Sarcoma, Solitary Fibrous Tumors, Squamous Cell Carcinoma of Head and Neck, Stomach Neoplasms
Enrollment 146 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov